Madsen OTOflex 100 User manual

User Manual
Part No. 7-50-00000
Doc. No. 7-50-0000/U2

Copyright notice
No part of this User Manual or program may be reproduced, stored in a retrieval system, or trans-
mitted, in any form or by any means, electronic, mechanical, photocopying, recording, or other-
wise, without the prior written consent of GN Otometrics A/S.
Copyright©
2003, GN Otometrics A/S
Printed in Denmark by GN Otometrics A/S, Denmark
All information, illustrations, and specifications in this manual are based on the latest product in-
formation available at the time of publication. GN Otometrics A/S reserves the right to make
changes at any time without notice.
Technical support
Please contact your supplier.

GN Otometrics A/S iii
Contents
1 Introduction
1.1 The OTOflex 100 .......................................................................................................................... 7
1.2 The OtoDiagnostic Suite PC software ........................................................................................ 8
1.3 About this manual....................................................................................................................... 8
1.4 Typographical conventions......................................................................................................... 9
1.4.1 The use of WARNING, CAUTION and NOTE .................................................................. 9
1.4.2 Navigation ....................................................................................................................... 9
2 When you receive the OTOflex 100
2.1 Unpacking.................................................................................................................................. 11
2.2 Storing the OTOflex 100 ........................................................................................................... 11
2.3 Views of the OTOflex 100 ......................................................................................................... 12
2.3.1 Front view...................................................................................................................... 12
2.3.2 Top view ........................................................................................................................ 12
2.3.3 Bottom view .................................................................................................................. 13
2.3.4 Reverse side view ..........................................................................................................13
2.3.5 The charger.................................................................................................................... 14
2.4 Probe .......................................................................................................................................... 15
2.5 Assembly and installation ......................................................................................................... 15
2.5.1 Location ......................................................................................................................... 15
2.5.2 Powering the OTOflex 100 ........................................................................................... 16
2.5.3 The charger.................................................................................................................... 17
2.5.4 Connecting the OTOflex 100 probe and insert phone ............................................... 18
2.6 Display & keypad ....................................................................................................................... 21
2.6.1 Keys, terms, functions ................................................................................................... 21
2.6.2 Entering and editing data and settings....................................................................... 21
2.7 Device setup............................................................................................................................... 22
3 Preparing for testing
3.1 Preparing the test environment ...............................................................................................23
3.1.1 The physical environment............................................................................................. 23

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iv GN Otometrics A/S
3.1.2 Hygienic precautions..................................................................................................... 23
3.2 Preparing the probe.................................................................................................................. 23
3.2.1 Preparing for screening ................................................................................................ 23
3.2.2 Preparing for diagnostic and clinical testing............................................................... 25
3.3 Preparing the OTOflex 100 ....................................................................................................... 26
3.3.1 Probe test....................................................................................................................... 26
3.3.2 Fitting the eartip on the probe .................................................................................... 27
3.3.3 Selecting a patient ........................................................................................................28
3.3.4 Selecting the user.......................................................................................................... 29
3.3.5 Selecting the test type .................................................................................................. 30
3.4 Preparing the patient................................................................................................................ 30
3.4.1 Selecting the ear and fitting the probe with eartip in the ear canal ........................ 31
4Tests
4.1 Starting up the test ................................................................................................................... 33
4.2 Tympanometry .......................................................................................................................... 34
4.2.1 Tympanometric sweep.................................................................................................. 34
4.3 Reflex testing............................................................................................................................. 36
4.3.1 Acoustic Reflex Threshold............................................................................................. 37
4.3.2 Acoustic Reflex Decay ................................................................................................... 38
4.3.3 Eustachian Tube Function - Perforated (ETF-P) ........................................................... 41
5 Setup
5.1 Measurement settings............................................................................................................... 43
5.1.1 Changing measurement settings ................................................................................. 43
5.1.2 Uploading measurement settings to the OtoDiagnostics Suite ................................. 44
5.1.3 Tympanometric settings ............................................................................................... 44
5.1.4 Reflex Threshold settings.............................................................................................. 46
5.1.5 Reflex Decay settings .................................................................................................... 49
5.2 Device settings........................................................................................................................... 50
5.3 Sequence setup.......................................................................................................................... 51
5.3.1 Procedure options ......................................................................................................... 51
6 Viewing results
6.1 Viewing all results ..................................................................................................................... 53
6.2 Viewing current results ............................................................................................................. 53

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GN Otometrics A/S v
7 Printing results
7.1 Printing a single-page report ................................................................................................... 55
7.2 Printing current results ............................................................................................................. 55
8 Service and Maintenance
8.1 Equipment failure ..................................................................................................................... 57
8.2 Service and repair...................................................................................................................... 57
8.3 Maintenance.............................................................................................................................. 58
8.3.1 Calibration ..................................................................................................................... 58
8.3.2 Probe cleaning and maintenance ................................................................................ 58
8.3.3 Cleaning and disinfecting the probe tip...................................................................... 58
8.3.4 Cleaning and disinfecting the test cavity .................................................................... 61
8.3.5 Changing the acoustic filter ......................................................................................... 61
8.3.6 Cleaning the OTOflex 100 ............................................................................................ 62
8.3.7 Eartips ............................................................................................................................ 63
8.3.8 Disposal of disposable articles...................................................................................... 63
8.3.9 Batteries and charger.................................................................................................... 63
8.3.10 Safety information ........................................................................................................64
8.3.11 Environmental protection ............................................................................................ 64
9 Troubleshooting
10 Safety
10.1 Symbols used ............................................................................................................................. 67
10.1.1 OTOflex 100 symbols..................................................................................................... 67
10.1.2 Charger unit symbols .................................................................................................... 68
10.2 Warning notes ........................................................................................................................... 69
10.2.1 OTOflex 100 warning notes.......................................................................................... 69
10.2.2 Charger unit warning notes ......................................................................................... 71
10.3 Manufacturer............................................................................................................................. 71
10.3.1 Responsibility of the manufacturer ............................................................................. 71
11 Technical Specifications
11.1 Otoflex 100 ................................................................................................................................ 73

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vi GN Otometrics A/S
11.1.1 Compliance measuring system ..................................................................................... 73
11.1.2 Acoustic Reflex .............................................................................................................. 73
11.1.2.1 Contra lateral Stimulation.......................................................................... 73
11.1.2.2 Ipsilateral Stimulation ................................................................................ 74
11.1.3 Air pressure system .......................................................................................................74
11.1.4 Data interface................................................................................................................ 74
11.1.5 Type identification ........................................................................................................ 75
11.1.6 Power supply ................................................................................................................. 75
11.1.7 Dimensions and weight ................................................................................................ 75
11.2 Charger unit............................................................................................................................... 75
11.2.1 Type identification ........................................................................................................ 75
11.2.2 Power supply ................................................................................................................. 75
11.2.3 Dimensions and weight ................................................................................................ 76
11.3 Operating mode ........................................................................................................................ 76
11.4 Operating environment ............................................................................................................ 76
11.5 Transport and storage............................................................................................................... 76
11.6 Miscellaneous ............................................................................................................................ 76
11.7 Standards ................................................................................................................................... 77
11.8 Standard and optional accessories ...........................................................................................77
12 Glossary
12.1 Clinical Terminology.................................................................................................................. 79

OTOflex 100 User Manual
GN Otometrics A/S 7
1 Introduction
Thank you for purchasing the OTOflex 100.
This manual is your guide to the use and maintenance of your
OTOflex 100.
We strongly recommend that you read it carefully before using your
OTOflex 100 for the first time.
We also recommend that you take particular note of the cleaning and
maintenance instructions. Failure to use and maintain the OTOflex
100 correctly may void your warranty.
1.1 The OTOflex 100
Intended use
The OTOflex 100 is an audiodiagnostic device intended for clinical,
diagnostic and screening tympanometry and reflex measurements
performed by audiologists, ENTs and other health care profession-
als. It is designed for use on infants, children and adults, and is light-
weight, fast, reliable, and easy to use.
The OTOflex 100 uses technologies which are highly effective for
clinical and screening purposes. Tympanometry and acoustic reflex
measurements measure the mechanic response of the middle ear
and determines whether the related physiological structures are
functioning correctly or not.
The OTOflex 100 probe is extremely lightweight (only 4.5 grams),
and comes with comfortable, easy to insert probe tips. This makes it
ideal for use with children and adults.
The OTOflex 100 can be configured for a wide variety of tests, and it
can be operated entirely manually or programmed for the user’s
own combination of manual and automatic operation. In user-pro-
grammable tests the user can select the default parameters of a par-
ticular test, and combine tests to form a sequence of preset tests.

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User Manual OTOflex 100
1.2 The OtoDiagnostic Suite PC software
The OTOflex 100 is designed for operating with the OtoDiagnostic
Suite. You can:
• Upload data to and download data from the OtoDiagnostic
Suite.
• Define your measurement settings in the OtoDiagnostic Suite
and download them to the OTOflex 100.
•OperatetheOTOflex 100 independently of the OtoDiagnostic
Suite, and subsequently transfer test results and patient data.
Wherever relevant, references to the OtoDiagnostic Suite is listed in
this User Manual. For specific instructions on how to use the OtoDi-
agnostic Suite, please see the OtoDiagnostic Suite User Manual.
1.3 About this manual
This User Manual contains a description of the main functions of the
OTOflex 100. GN Otometrics A/S recommends that you make your-
self familiar with the following issues:
Installation
The sections Section 2.1, ‘Unpacking” on page 11, Section 2.3, ‘Views
of the OTOflex 100” on page 12, and Section 2.5, ‘Assembly and in-
stallation” on page 15 contain a full description of unpacking in-
structions, controls and socket connections, and how to install the
device.
Safety
This User Manual contains information and warnings which you
must follow at all times to ensure the safe performance of the
OTOflex 100. Local government rules and regulations, if applicable,
should also be followed at all times.
Please see the overview of device labelling in Section 2.3, ‘Views of
the OTOflex 100” on page 12 and read the warning notes in Section
10.2, ‘Warning notes” on page 69.
Training
It is recommended that you read this manual before you start oper-
ating the OTOflex 100 so that you become familiar with the device
before testing on a patient.
Maintenance and cleaning
For instructions on how and when to clean the OTOflex 100, please
see Chapter 8, “Service and Maintenance” on page 57.

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OTOflex 100 User Manual
1.4 Typographical conventions
1.4.1 The use of WARNING, CAUTION and NOTE
For safety reasons and appropriate use of the OTOflex 100, the man-
ual contains WARNINGS, CAUTIONS and NOTES, which you
should read carefully. The use of these is defined as follows:
WARNING:
A warning indicates that there is risk of danger to persons and/or
device.
Caution:
A caution indicates that there is risk of damage to the device.
Note:
A note indicates that you should take special notice.
1.4.2 Navigation
Buttons you must press and screen functions you must select are
shown in bold type, as for instance in:
• Scroll to the Test icon on the Main Menu and press Select.
For details on navigating see Section 2.6, ‘Display & keypad” on
page 21, for entering and editing data see Section 2.6.2, ‘Entering
and editing data and settings” on page 21.

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User Manual OTOflex 100

OTOflex 100 User Manual
GN Otometrics A/S 11
2 When you receive the OTOflex 100
2.1 Unpacking
1. Unpack your OTOflex 100 carefully.
When you unpack the OTOflex 100, it is a good idea to keep
the packing material in which it was delivered. If you need to
send the OTOflex 100 in for service, the original packing mate-
rial will protect against damage during transport, etc.
2. Inspect the equipment for possible visual damage.
If damage has occurred, do not put the OTOflex 100 into oper-
ation. Contact your supplier for assistance.
3. Make sure that you have received all necessary parts and
accessories.
If your package is incomplete, contact your supplier.
2.2 Storing the OTOflex 100
If you need to store the OTOflex 100 before you put it into operation,
follow the guidelines below:
•StoretheOTOflex 100 and accessories in the box provided to
protect the equipment from damage.
•StoretheOTOflex 100 as stated in Section 11.5, ‘Transport and
storage” on page 76.

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User Manual OTOflex 100
2.3 Views of the OTOflex 100
This section provides you with views of the OTOflex 100 and its
charger from various angles.
You will find a description of the keypad, and how to navigate and
enter data in the OTOflex 100 in Section 2.6, ‘Display & keypad” on
page 21.
2.3.1 Front view
2.3.2 Top view
- Ear selector
- On/Off button
- OK button
- Scroll wheel
- Softkeys
LDC Display
Loudspeaker
Keypad with:
Probe
Device colour code
Probe socket
Probe
Contra-lateral socket
Pneumatic
connection

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OTOflex 100 User Manual
2.3.3 Bottom view
2.3.4 Reverse side view
Charger cavity
Battery casing with cover
Probe
Label
Track for probe cable
mounted with short cable
Label

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User Manual OTOflex 100
2.3.5 The charger
Front view
Rear view
Charger tab
Probe test cavity
Charging diode
for the device
Base
Mains socket

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OTOflex 100 User Manual
2.4 Probe
2.5 Assembly and installation
2.5.1 Location
To ensure safe performance, the OTOflex 100 must be correctly in-
stalled, and the requirements listed in Chapter 10, “Safety” on page
67 and Chapter 11, “Technical Specifications” on page 73 must be
complied with.
The OTOflex 100 can be used as a handheld device with no specific
requirements to location. However, keep the OTOflex 100 away from
all liquids and sources of heat (for detailed specifications, see Section
11.4, ‘Operating environment” on page 76.
Testing is facilitated by a moderately quiet room. A sound cabin or
sound treated room is not necessary.
Probe body
Probe tip
Threaded ring
Probe test cavity

16 GN Otometrics A/S
User Manual OTOflex 100
Assembly
Before you power the charger, mount the charger on the charger
base as shown:
2.5.2 Powering the OTOflex 100
The OTOflex 100 is powered by batteries and the charger for the
OTOflex 100 is mains powered. See the following descriptions for
powering.
Batteries
The OTOflex 100 is delivered with batteries. Before you can operate
the OTOflex 100, you must insert the batteries:
Use only the batteries listed in Chapter 11, “Technical Specifica-
tions” on page 73.
1. The first time you insert the batteries, take out the battery
cover from the bottom of the OTOflex 100: To do so, hold the
device in one hand and pull on the slip attached to the battery
cover. This will free the cover from the battery holder. When
the cover is free, remove the slip.
Charger body
Charger base
Screws
Charger base and charger with screws etc.

GN Otometrics A/S 17
OTOflex 100 User Manual
2. Insert the batteries as shown.
3. To put the battery cover back in place, insert the cover with the
curved edge facing upwards in the opening. Press the cover
inwards and downwards until it clicks into place.
4. The next time you change batteries, press the cover inwards
and upwards until it is released and snaps out of place.
Battery status
When the OTOflex 100 is powered on, it shows the current status of
the battery in the top right corner of the display.
2.5.3 The charger
Powering
Caution:
Operating at the wrong voltage may blow the fuses! See the label on
the charger for input voltage.
Caution:
Before you connect the power cable to the charger, make sure that
the voltage from the electrical mains outlet matches the voltage
shown on the identification label on the charger.
+
++
+
100% 60% 30% 0%

18 GN Otometrics A/S
User Manual OTOflex 100
1. Connect the power cable of the OTOflex 100 charger to a
power outlet.
2. Plug the end (A) of the supplied power cable into the power
inlet on the charger (see below) and plug the other end into
the power outlet.
3. The OTOflex 100 can be used immediately when you place it in
the charger.
4. When the OTOflex 100 is placed in the charger, you can follow
the status of the charging process on the charging diode on the
charger front.
When charging, the diode indicates the following:
• Green, steady: The OTOflex 100 is fully charged.
• Yellow, steady: The OTOflex 100 is charging.
• Green, flashing: There is a fault in the charger. Contact
your supplier.
5. Leave the device to charge overnight.
2.5.4 Connecting the OTOflex 100 probe and insert phone
The following applies both to the OTOflex 100 Ipsi probe and the
E-A-R TONE 3A insert phone.
Connecting the probe to the OTOflex 100
The OTOflex 100 comes with a probe for immittance testing. The
probe may be fitted with either a long or a short cable, depending on
how you wish to use the device.
A

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OTOflex 100 User Manual
1. Plug the probe and/or insert phone plugs into the sockets on
top of the OTOflex 100 (see the illustration below). Do not use
force when you insert the plug.
The Ipsi probe The plug of the Ipsi probe goes into the probe socket. Make
sure that you insert the pin for the pneumatic pump into the
pneumatic connection.
The E-A-R TONE 3A insert phone The plug of the E-A-R TONE 3A insert phone goes into the
contra-lateral socket.
Caution:
When you disconnect the probe, do not pull the plug by the cable.
Grip the sleeve of the plug and free it by pulling it backwards.
The probe will not be released if you pull anywhere else than on the
sleeve of the plug.
Using the probe with the probe fixture
The probe fixture is a practical place to keep the probe whenever the
device is not in use, regardless of cable length, for instance when
charging the batteries.
For instance for screening purposes you can place the probe itself in
the probe fixture.
1. Plug the probe with the short cable in the probe socket.
2. Mount the probe fixture on the OTOflex 100. To do so, place
the fixture in the groove on top of the OTOflex 100.
Probe socket
Probe
Contra-lateral socket
Pneumatic
connection

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User Manual OTOflex 100
3. Snap the wings into place by pressing them downwards.
4. Place the probe in the probe fixture.
Using the probe without the probe fixture
For instance for clinical and diagnostic purposes you can use the
probe without the probe fixture.
5. If required, remove the probe from the probe fixture.
6. Remove the probe fixture from the OTOflex 100. To do so,
press the wings of the probe fixture gently towards each other,
and ease the fixture out of its groove.
Wings
Probe fixture
Probe fixture
Probe
Wings
Probe fixture